HealthyPhase 1NCT00619736
Study Evaluating the Safety, Tolerability and Pharmacokinetics of NSA-789 in Healthy Japanese Male Subjects
A Phase 1 study testing NSA-789 in people with Healthy, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
This study will provide an initial assessment of the safety, tolerability and pharmacokinetics (PK) of NSA-789 after administration of ascending single oral doses to healthy Japanese male subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- NSA-789
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Sep 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men aged 20 to 45 years inclusive at screening.
- Healthy as determined by the investigator on the basis of screening evaluations.
Who cannot join
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- Use of any investigational drug within 90 days before study day 1 or prescription drug within 30 days before study day 1
- Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead electrocardiograms (ECGs), or clinical laboratory test results.
About this study
Official title: Ascending Single Dose Study of the Safety, Tolerability and Pharmacokinetics of NSA-789 Administered Orally to Healthy Japanese Male Subjects
This study will provide an initial assessment of the safety, tolerability and pharmacokinetics (PK) of NSA-789 after administration of ascending single oral doses to healthy Japanese male subjects. This is a randomized, double-blind, placebo-controlled, inpatient, sequential-group study conducted under fasting conditions at a single investigational site. Each subject will participate in only 1 dose group and will receive only 1 dose of test article.
- Conditions
- Healthy
- Being tested
- NSA-789, Placebo
- Keywords
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSA-789Drug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| NSA-789 | Experimental | Not described Receives: Drug: NSA-789 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Measured: 3 months
Secondary outcomes (1)
Pharmacokinetics
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619736
- Sponsor's protocol ID
- 3230A1-1001
- Status last verified
- Jan 2009
- First submitted
- 8 Feb 2008
- Last updated
- 30 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ascending Single Dose Study of the Safety, Tolerability and Pharmacokinetics of NSA-789 Administered Orally to Healthy Japanese Male Subjects
- ClinicalTrials.gov ID
- NCT00619736
- Acronym / sponsor ID
- 3230A1-1001
- Conditions
- Healthy
- Keywords
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 21 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will provide an initial assessment of the safety, tolerability and pharmacokinetics (PK) of NSA-789 after administration of ascending single oral doses to healthy Japanese male subjects. This is a randomized, double-blind, placebo-controlled, inpatient, sequential-group study conducted under fasting conditions at a single investigational site. Each subject will participate in only 1 dose group and will receive only 1 dose of test article.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSA-789 | Experimental | Drug: NSA-789 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men aged 20 to 45 years inclusive at screening.
- Healthy as determined by the investigator on the basis of screening evaluations.
Key exclusion criteria (3 listed)
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- Use of any investigational drug within 90 days before study day 1 or prescription drug within 30 days before study day 1
- Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead electrocardiograms (ECGs), or clinical laboratory test results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NSA-789 | Drug | NSA-789 |
| Placebo | Other | Placebo |
Primary outcome
Safety and Tolerability
Time frame: 3 months
1 secondary outcome
Pharmacokinetics
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NSA-789 in people with Healthy, run by Wyeth is now a wholly owned subsidiary of Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2009.